The regulatory environment / Claudio Bernardi and Marco Brughera --Toxicological development : roles and responsibilities / Franck Chuzel and Bernard Ruty -- Contract research organizations / Maurice Cary -- Safety pharmacology / Claudio Arrigoni and Valeria Perego -- Formulations, impurities, and toxicokinetics / Claude Charuel -- General toxicology / Alberto Lodola -- Genetic toxicology / Peggy Guzzie-Peck, Jennifer C. Sasaki, and Sandy K. Weiner -- Developmental and reproductive toxicology / Jeanne Stadler -- Data analysis, report writing, and regulatory documentation / Monique Y. Wells -- Risk management / Alberto Lodola